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Covid-19 Vaccine Pfizer/BioNTech 90% Effective - Update 11/9/20


Formula280SS
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Oh interesting. Updating my own information. Our largest pharmacy chain, Wegmans (grocery stores), has accepted a deal with US DHS to be one of the 60% of pharmacies nationwide to distribute the vaccine. So they are willing and to make the investment.  I don't see my my little CVS can do it - there is no space behind their counter for a freezer. But Wegmans has large pharmacies.

 

But 60% of pharmacies is a long way from 100% and even further from doctor's offices.  My insurance does not cover vaccines given at pharmacies!  Doctors only.

 

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45 minutes ago, PelicanBill said:

One thing that we may be talking about soon is the logistics complexity.  Beside the hard job of parceling out limited supplies to health workers and elderly to start, the vaccine must be shipped and stored at -70c .

 

You should not need refrigerated trucks at those temperature, the scientists yesterday were saying it can be shipped in dry ice (-78c) and once unpacked at the other end can be stored in a normal fridge but at the point it's removed from the dry ice, it has to be used in 5 day or becomes unviable.

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Butting in a bit - one of the techs at my local Walgreens told me a few weeks ago that the chain was working with the vaccine makers regarding distribution.  She said it was going to be a 'bear' starting up, but she felt pretty confident.  At least that day!  I was surprised myself, since I had mentioned the extreme cold storage issue.  

 

I believe that both CVS and Walgreens will be sending folks to long term care homes and retirement homes to administer shots, as well as shots at the stores for others as they work through the tiers eligible for shots during a given phase.  I would expect it to be by appointment, myself.  

 

And regarding room - well, just guessing but wait for the construction guys to come through in the not horribly distant future (I hope!) to reconfigure stores a bit.  

https://www.propublica.org/article/most-states-arent-ready-to-distribute-the-leading-covid-19-vaccine

 

 

@PelicanBill, might be a bit early but I'd check with your insurer.  I suspect any of the majors will be revamping coverage to extend to more providers.  As far as I know, Medicare has already stated it'll be no cost at point of service for the classic plan, wherever that may be.  I may be wrong, but I'm reasonably sure there will be a deluge of communications going forward.

Edited by greykitty
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41 minutes ago, PelicanBill said:

 

 My insurance does not cover vaccines given at pharmacies!  Doctors only.

Any vaccines purchased by the government through Operation Warp Speed will be given at no cost.

https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html

 

"What are you doing to make these products affordable for Americans?

The Administration is committed to providing free or low-cost COVID-19 countermeasures to the American people as fast as possible. Any vaccine or therapeutic doses purchased with US taxpayer dollars will be given to the American people at no cost."
 

 

Edited by njhorseman
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On 11/13/2020 at 7:13 AM, Formula280SS said:

 

Thanks for the input.  There sure is a lot more to be disclosed about what they have learned. 

 

Another uptick in discussion is the monthly post vaccination 'at home test capabilities of various providers so that the duration of the effectiveness can be measured.

 

A question (if you want to answer) ~ do you continue to be tested on any periodic basis for the duration and effectiveness of the vaccine response you've experienced?

 

Again, thanks.

I am happy to give as much info as I am able. There are no disclosure restrictions in the informed consent documentation for the study. 

 

Remember, I do not know at this time if I received the vaccine or a placebo (a saline injection). The study is six visits total. Visit 1 was intake and first shot (almost half a day). Visit 2 was shot #2, right on the day due for the interval. Visit 3 was 2 or 3 weeks after that, and was just blood work. Visit 4 is in January, visit 5 is, I believe, at the 1 year mark, and the final visit is at the 22 month mark.

 

If I feel sick, I am to self-administer a nasal swab test and contact my research doctor, who will either recommend I come in for extensive blood work or that I not  come in at all. The results of this testing are not disclosed to me. If I want to know my  COVID status, I have to be tested like anyone else.

 

In the 7 days after each shot, I filled out an electronic diary of temperature and symptoms, if any. (That would be the "reaction to the shot" tracking.) I now weekly fill out a survey that asks if I have had any COVID-like symptoms. The one week I answered that I'd experienced a few symptoms, I got a call from my coordinator the following day for a followup interview. She told the doctor and he decided I did not need to come in.

 

The direct answer to your question is yes, I am evaluated regularly. I'm certain Pfizer knows whether I have had a vaccine response, but I do not know and am continuing to take precautions. We were specifically told that participating in the study should not change anything about our reactions to the pandemic.

 

I believe I received vaccine. I have had a saline injection before and this felt different going in. But if a vaccine becomes available for me, I will consult with the research folks before deciding whether to get it.

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4 hours ago, plainsstormchaser said:

I am happy to give as much info as I am able. There are no disclosure restrictions in the informed consent documentation for the study. 

 

Remember, I do not know at this time if I received the vaccine or a placebo (a saline injection). The study is six visits total. Visit 1 was intake and first shot (almost half a day). Visit 2 was shot #2, right on the day due for the interval. Visit 3 was 2 or 3 weeks after that, and was just blood work. Visit 4 is in January, visit 5 is, I believe, at the 1 year mark, and the final visit is at the 22 month mark.

 

If I feel sick, I am to self-administer a nasal swab test and contact my research doctor, who will either recommend I come in for extensive blood work or that I not  come in at all. The results of this testing are not disclosed to me. If I want to know my  COVID status, I have to be tested like anyone else.

 

In the 7 days after each shot, I filled out an electronic diary of temperature and symptoms, if any. (That would be the "reaction to the shot" tracking.) I now weekly fill out a survey that asks if I have had any COVID-like symptoms. The one week I answered that I'd experienced a few symptoms, I got a call from my coordinator the following day for a followup interview. She told the doctor and he decided I did not need to come in.

 

The direct answer to your question is yes, I am evaluated regularly. I'm certain Pfizer knows whether I have had a vaccine response, but I do not know and am continuing to take precautions. We were specifically told that participating in the study should not change anything about our reactions to the pandemic.

 

I believe I received vaccine. I have had a saline injection before and this felt different going in. But if a vaccine becomes available for me, I will consult with the research folks before deciding whether to get it.

 

That's interesting my experience on the Oxford vacine is somewhat similar but with several differences.
My journey started back on 16 June 2020.

Initially I went in for screening which involved an antibody test, bloods and lots of questions, Once accepted I returned a week later for my first (and at the time it was to be one) shot. 

 

Following my first shot, I kept a daily online diary for a week and began taking a weekly swab test which I still do today and will continue to do until the end of the trial.

 

Here are the first two differences, our placebo is a meningitis vaccine and we have to do a weekly swab test which we do get the results for and of course I got the results of the initial antibody test as you can't have antibodies to take part.

 

My first return appointment was on 28 days to do blood work and review my diary which after the first week of daily entries became a weekly diary.

 

On 19th August (two months after the initial shot) I had a second shot, this was optional as it was never agreed at the start, the booster shot needed to be taken 4-12 weeks after the initial shot.

 

After the booster I needed to do a further weekly diary and return again for blood work after 28 days.

 

This is how my appointments look now:

 

image.png.a6af9288bf1ceed305626cc05e5b059a.png

 

I can only say the shot was absolutely nothing, like a flu shot I just had a little muscle ache for a few hours and nothing more. They gave me a tape to measure any swelling or redness at the injection point but there was nothing, I could not even find the puncture point!

 

Of course like @plainsstormchaser I have no idea if I had the vaccine or the placebo but whichever vaccine I received it was nothing.

 

I too am free to disclose any information and although it might not be so interesting as it won't be the first vaccine release, I am also happy to answer any questions.

Edited by ziggyuk
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4 hours ago, plainsstormchaser said:

I believe I received vaccine. I have had a saline injection before and this felt different going in. But if a vaccine becomes available for me, I will consult with the research folks before deciding whether to get it.

I am in the same trial, however I believe that I received the placebo. I remember the coordinator telling us that the only way that they will know if the vaccine is effective is if enough placebos catch it. Kind of morbid, but that is the only way. So far, it looks like it is the results that they expected.

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14 hours ago, plainsstormchaser said:

If I feel sick, I am to self-administer a nasal swab test and contact my research doctor, who will either recommend I come in for extensive blood work or that I not  come in at all. The results of this testing are not disclosed to me. If I want to know my  COVID status, I have to be tested like anyone else.

 

Are you saying that if you test positive they won't tell you and allow you to continue your daily life? Or do they recommend you have a second test in the same way as the general public.

 

It can't be right to withhold the results and knowingly allow you to infect others and if you have a second test, they might as well have given you the result in the first place, it makes no sense.

 

The problem with only doing a test if you feel sick is they won't pick up asymptomatic people, we already know lots of people get the virus without ever knowing and they become spreaders.
The one thing they are not sure about is if people with the vaccine can still spread the virus, a weekly swab test for all participants (I think) would help answer this as it tells them if you have virus in your raspatory tract.

 

My weekly swab results are received by both text and email and also appears on my medical records, they get sent through exactly the same system the general pubic use, my test day is Thursday afternoon and I always get the results of a Sat/Sun morning, I got my results today at 6.30AM.

 

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Thank you both for sharing all this information about the trials.  And also thank you for participating.  I find all of this fascinating and appreciate you sharing your experiences.

I know this is a cruise board, but I also think that an effective vaccine will have a profound effect on the future of cruising.

Please continue to share any information you feel is relevant or interesting.

Thank you and stay healthy!

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5 hours ago, ziggyuk said:

 

Are you saying that if you test positive they won't tell you and allow you to continue your daily life? Or do they recommend you have a second test in the same way as the general public.

 

The second. I need to have a second test for public health and quarantine reasons. 

 

As for the rest: remember that they already know whether I had antibodies at the start, whether I gained them with the vaccine, what my mRNA load from the vaccine is, and so forth. There is blood work done each test. So they know if I'm trending differently than other similar test subjects.

 

I understand your point about asymptomatic carriers. But I think your solution would totally overwhelm the research capability. I would have preferred to see us asked to administer and send a nasal swab monthly in addition to the doctor visits. But this is a phase 2/3 study -- the study protocols aren't that frequent in later-phase trials. (This is my second trial and the fourth trail for a member of my family in the past 15 years)

 

If I am an asymptomatic carrier, what difference will that make to the study? For the research purposes only, I contracted COVID. It makes a difference outside the study, but again that is testing which has to be conducted in the public health or doctor's office realms, not as part of the research.  

 

I think the trigger of being symptomatic is to ensure that all symptomatic cases are caught in the research, as they are also needing to know the impact on those who contract COVID. But asymptomatic cases will be caught by the blood testing, IMO.

 

I should note, these are all statements of opinion. I could be all wet about the reasoning behind those decisions.

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19 hours ago, Coreysgrl06 said:

Plainsstormchaser have you felt any side effects? If you can’t share I understand. I read one article where an individual mentioned feeling like he had a severe hangover with body aches after his vaccine. 

With one of the two shots I had more than normal soreness around the injection site for about 36 hours. No other symptoms.

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16 hours ago, ziggyuk said:

Here are the first two differences, our placebo is a meningitis vaccine and we have to do a weekly swab test which we do get the results for and of course I got the results of the initial antibody test as you can't have antibodies to take part.

 

I see with this structure why it's important to have the weekly testing. And I understand why the results are disclosed. I'm not certain of this, but I wonder if an additional difference is that in the UK you do this through your doctor or something funded by NHS, while in the US I am doing it through a third-party (commercial) research center associated with a doctor (I've seen the doctor exactly once).

 

I'm not saying either is preferable to the other, just that it is a difference. And of course my assumption may be completely wrong. 

 

If you show up with antibodies, what is the next step?

 

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15 hours ago, zdcatc12 said:

I am in the same trial, however I believe that I received the placebo. I remember the coordinator telling us that the only way that they will know if the vaccine is effective is if enough placebos catch it. Kind of morbid, but that is the only way. So far, it looks like it is the results that they expected.

 

I believe the Pfizer trial is also gauging whether there is an impact on disease progression and outcome for those who get COVID in spite of the vaccine. I'd have to reread the printout of the informed consent stuff to be sure. It will be interesting to see if the 90% holds when the results of the next group are announced.

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Hey, for those interested -- I tried to compile everything I've come across on the COVID-related developments in the cruising world the past week -- and also went out on a limb with a few predictions...not sure if they are a truly balanced belief or hopeful projection at this point 🤷‍♂️

 

https://2of8000.website/so-yeah-about-that-floating-petri-dish-thing/

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3 hours ago, plainsstormchaser said:

 

I see with this structure why it's important to have the weekly testing. And I understand why the results are disclosed. I'm not certain of this, but I wonder if an additional difference is that in the UK you do this through your doctor or something funded by NHS, while in the US I am doing it through a third-party (commercial) research center associated with a doctor (I've seen the doctor exactly once).

 

I'm not saying either is preferable to the other, just that it is a difference. And of course my assumption may be completely wrong. 

 

If you show up with antibodies, what is the next step?

 

 

You could be right because everything is run through our NHS.

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3 hours ago, plainsstormchaser said:

Hey, for those interested -- I tried to compile everything I've come across on the COVID-related developments in the cruising world the past week -- and also went out on a limb with a few predictions...not sure if they are a truly balanced belief or hopeful projection at this point 🤷‍♂️

 

https://2of8000.website/so-yeah-about-that-floating-petri-dish-thing/

 

A really interesting read just a couple of things.

 

Cruise lines could make a record of immunization a required document but I think cruise lines will probably have realised this will have a financial and legal implications for them, they might not want to have. Especially if governments do not mandate it or in some way standardise it.

 

A PCR test would take far too long to process and cost to much on departure day. A lateral flow test could be used but is not as accurate.

 

All in all a good article.

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1 hour ago, nomad098 said:

A PCR test would take far too long to process and cost to much on departure day. A lateral flow test could be used but is not as accurate.

There's a new 20 minute molecular test developed by a company called Cue Health that's being rolled out in the US. Here in New Jersey we're among the first states that will receive a supply of the test. The company has received $481 million in federal government funding to speed up production of the test. Here's some information about it:

https://medcitynews.com/2020/10/cue-health-gets-481m-to-expand-production-of-rapid-coronavirus-test/

 

"For its part, Cue claims its Covid-19 test has a 98.7% sensitivity rate, meaning it identifies the virus most of the time, and a 97.6% specificity rate, indicating relatively few false positives. The HHS funding came after Mayo Clinic conducted a prospective study to evaluate the accuracy of its test, though it has not yet published the full results."

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I am enrolled in the Novavax phase clinical trial in UK

Initial visit had thorough physical exam and self administered throat and nasal swabs

also had blood test for antibodies 

came back negative within 48 hours

I have second vacc next week[will not know if in active or placebo group until end of trial]

If I have symptoms I need to self test and post swabs for 3 consecutive days and fill in e diary

 

If I am admitted to hospital for any reason my trial id means medical staff can check whether  I received active or placebo and treat me accordingly

also if it becomes apparant I should be eligible to receive an effectitive vaccine sooner I will be  released from trial 

 

  

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  • 3 weeks later...

 An update on the Pfizer study that I am in, now that a vaccine may be out soon. I received a letter from the chief medical director and principal investigator for the study that states "We know that access to a potential vaccine is top of mind for many trial participants. Pfizer and BioNTech are actively exploring potential ways to change the study to create a process that would allow interested participants in the placebo group who meet the eligibility criteria for early access in their country to "cross-over" to the vaccine group in the study. To make a change like this, the companies would first need input and approval from regulatory authorities. We will update you as we have more info on this."

 

 They told us that this is probably what Pfizer would do, i.e. let the placebos get the vaccine. However, in order to continue in the trial, the vaccine would obviously need to be the Pfizer one and not one of the others.

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4 minutes ago, zdcatc12 said:

 An update on the Pfizer study that I am in, now that a vaccine may be out soon. I received a letter from the chief medical director and principal investigator for the study that states "We know that access to a potential vaccine is top of mind for many trial participants. Pfizer and BioNTech are actively exploring potential ways to change the study to create a process that would allow interested participants in the placebo group who meet the eligibility criteria for early access in their country to "cross-over" to the vaccine group in the study. To make a change like this, the companies would first need input and approval from regulatory authorities. We will update you as we have more info on this."

 

 They told us that this is probably what Pfizer would do, i.e. let the placebos get the vaccine. However, in order to continue in the trial, the vaccine would obviously need to be the Pfizer one and not one of the others.

 

That's fabulous news and a nice little payback for your efforts, I don't think I will be offered that on the Oxford vaccine.

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